A Study to Compare Two Different Anti-HIV Drug Regimens

• Status: Completed
• Trial end date: 2001-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study compares 2 different anti-HIV drug regimens to determine which is the most effective in lowering the amount of HIV in the blood. The anti-HIV drugs used in this study are 2 protease inhibitors (nelfinavir and ritonavir), 2 nucleoside reverse transcriptase inhibitors (stavudine and didanosine), and 1 nonnucleoside reverse transcriptase inhibitor (nevirapine).

These drug combinations have been previously studied in adults, but there is limited information on how well they work in HIV-infected children. It is important to develop drug combinations which are effective at suppressing the HIV virus in children.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Didanosine; HIV Protease Inhibitors; Nelfinavir; Nevirapine; Protease Inhibitors; Ritonavir; Stavudine

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are between 4 months and 21 years of age (consent of parent or guardian required if under 18).

• Are HIV-positive.

• Have a viral level of at least 4,000 copies/ml.

• Have a CD4 cell count of at least 750 (under 12 months of age), at least 500 (1 to 5 years of age), or at least 200 (6 years of age or older) cells/mm3 within the past 4 months or a CD4 percent of 15 percent or higher within the past 4 months.

• Have received the same continuous antiretroviral therapy for the past 16 weeks.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have an active opportunistic and/or serious bacterial infection.

• Have been diagnosed with a malignancy.

• Have received prior treatment with certain antiretroviral medications.

• Are pregnant or breast-feeding.